Regulatory Affairs Specialist
5 hours ago
Job Description
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- About the Role: We are seeking a highly skilled and detail-oriented individual to join our team as an Assistant Manager for Regulatory Affairs & BioMed Tech Startup Management.">
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- Provide operational support and account management for biotech programs, ensuring smooth development and execution.">
- Facilitate connections for start-up companies with relevant service providers, including Contract Research Organizations (CROs), regulatory authorities, and quality system developers, to meet clinical trial and regulatory requirements.">
- Coordinate the application process for regulatory funding and assist companies with regulatory submissions, ensuring all processes comply with internal and external guidelines.">
- Serve as secretary for major program meetings, including panel assessments, milestone evaluations, and client meetings, ensuring internal controls are in place for compliance.">
- Conduct evaluations of program applications, arranging due diligence and assessment meetings, and providing input for continuous program enhancements.">
- Contribute to the ongoing improvement of program SOPs and processes, supporting the continuous development of the ecosystem.">
- Perform other related duties as assigned by the management team.">
Requirements
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- A bachelor's degree in life sciences, biomedical sciences, biomedical engineering, or other related fields, or an equivalent qualification.">
- At least 5 years of work experience, preferably in regulatory affairs or project management in the medical devices, pharmaceutical, or biopharma industries.">
- Experience in CRO/CDMO management, protocol development, Investigational New Drug (IND) filing, and regulatory submissions (FDA, NMPA, etc.) is an advantage.">
- Knowledge or experience in clinical trials and clinical affairs, particularly in medical devices and pharmaceuticals, is a plus.">
- Strong interpersonal, communication, and presentation skills. A proactive, self-motivated, and results-oriented approach.">
- Proficient in spoken and written English and Chinese, including Mandarin.">
- Candidates with higher education or professional qualifications and less experience will also be considered.">
What We Offer
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- A dynamic and innovative work environment within a leading hub for technology and innovation.">
- A 5-day work week with competitive annual leave and additional special leave.">
- Comprehensive medical benefits, including dental and annual check-ups from day one, with extended coverage for dependents.">
- Access to professional training and career development opportunities.">
- Convenient transportation options, with a bus network connecting various locations across the city.">
This is an exciting opportunity for an ambitious professional to contribute to the growth of biotech startups and make a significant impact in the life sciences sector.
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